BISNIS STRATEGI DAN ISO SERTIFIKASI

<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: center;">
<img height="151" src="http://t0.gstatic.com/images?q=tbn:ANd9GcRvOI3_-HVesEuBQcC_Esn9BNPPtlNuDxJA_6leqi2--t_KYQSQ" width="200" /></div>
<div style="text-align: justify;">
<div>
<br /></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 20.0pt; line-height: 115%;"><b><u><i><a href="http://www.blogger.com/SIEN%20Consultants%20is%20a%20leading%20Consultant%20&%20Training%20firm%20for%20ISO%209001%20%7C%20Sertifikat%20ISO%209001:2008,%20QMS,%20Sistem%20Manajemen%20Mutu%20%7C%20Konsultan%20ISO%20&%20Pelatihan%20ISO%209001%20Terbaik%20No.1%20Indonesia." target="_blank">CE Marking</a></i></u></b> Of <a href="http://indokonsultan.com/consultants-ce-i-konsultan-ce-marking-i-training-ce-mark/" target="_blank"><b><i><u>MEDICAL DEVICES</u></i></b> Guide<o:p></o:p></a></span></div>
<div>
<span style="font-size: 20.0pt; line-height: 115%;"><br /></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<br /></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<div>
<b><span style="font-size: 12.0pt; line-height: 115%;">                           </span><span style="line-height: 115%;"><span style="font-size: large;"> CONTENTS </span><span style="font-size: small;"><o:p></o:p></span></span></b></div>
</div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<b><span style="line-height: 115%;"><span style="font-size: large;"><br /></span></span></b></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="line-height: 115%;"><span style="font-size: large;">1.  Introduction
to the guide </span><span style="font-size: small;"><o:p></o:p></span></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="line-height: 115%;"><span style="font-size: large;"><br /></span></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<b><span style="font-size: 12.0pt; line-height: 115%;">2.    Regulation <o:p></o:p></span></b></div>
<div>
<b><span style="font-size: 12.0pt; line-height: 115%;"><br /></span></b></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<b><span style="font-size: 12.0pt; line-height: 115%;">2.1.   European directives regarding medical devices / In </span></b></div>
<div>
<b><span style="font-size: 12.0pt; line-height: 115%;">         VitroDiagnostic medical
devices and</span></b><b><span style="font-size: 12.0pt; line-height: 115%;"> their </span></b></div>
<div>
<b><span style="font-size: 12.0pt; line-height: 115%;">         consequences for placing on the
market in the </span></b></div>
<div>
<b><span style="font-size: 12.0pt; line-height: 115%;">         European Economic Area</span></b></div>
<div>
<b><span style="font-size: 12.0pt; line-height: 115%;"><br /></span></b></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">2.1.1.   General <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">2.1.2.  <b><u> Scope of the directives </u></b><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">2.1.3.   Essential requirements <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">2.1.4.   Importance of standards and their use <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">2.1.5.   <b><u>Problems of interpretation </u></b><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">2.1.6.   Coordination of Notified Bodies <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<br /></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">2.2.     Other directives to the taken into
consideration where applicable <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<b><span style="font-size: 12.0pt; line-height: 115%;">3.       With LNE / G-MED, how do you obtain the
certificates required for CE marking ? <o:p></o:p></span></b></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.1.     Identification of the manufacturer and, where
applicable, of the other parties <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.2.     <b><u><i>Characterization of the products concerned
</i></u></b><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.3.     Determining the applicable directive or
directives <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.4.     Determining the class of the device
(Directive 93/42/EEC case) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<br /></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.     <b><i>Choice of the conformity assessment
procedures </i></b><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.   Assessment
procedures for directives 90/385/EEC (AIMD) and 93/42/EEC (medical    <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">             devices)
<o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.1.<b><i>
Examination of design (Annex II section 4) </i></b><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.2. EC
type examination (Annex III) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.3.
Full quality assurance system (Annex II) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.4. <b><u><i>EC
verification</i></u></b> (Annex IV) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.5.
Production quality assurance (Annex V) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.6.<b><i><u>
Product quality assurance</u></i></b> (Annex VI) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;"> 3.5.1.7. DEcleration of comfermity ( annex VII
) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.8.
Particular case of software <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<br /></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.   Assessment procedures for directive 98/79/EC
(in vitro diagnostic medical devices) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.1.
<b><i><u>Design examination</u></i></b> (Annex IV section 4) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.2. EC
type examination (Annex V) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.3.
Full quality assurance system (Annex IV without sections 4 et 6) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.4. <b><i><u>EC
verification</u></i></b> (Annex VI) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.5.
Production quality assurance (Annex VII) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.6.
<b><u><i>Product quality assurance </i></u></b><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.7. EC
declaration of conformity (Annex III without section 6) <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.8.
<b><i><u>Verification of manufactured products </u></i></b><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.9.
Particular case of software <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<br /></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.       Horizontal themes <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.1.    <b><i><u>Risk analysis </u></i></b><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.    Clinical evaluation <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.1.
Guiding principles <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.  Practical approach <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.1.
<u><b><i>The notion of "clinical data" is pointless : </i></b></u><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.2.
Clinical evidence is obviously acquired from the start : <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.3.
The manufacturer provides sufficient data taken from the literature <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.4.<b><i><u>
The data consist of a clinical review. </u></i></b><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.5.  Data from the literature are not available, or
not sufficient : <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.5.1.
Compliance with the regulation relating to the conduct of <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">                      the
clinical investigation <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.5.2.
<b><u><i>Pre-clinical</i></u></b> data and contents of the clinical investigations plan <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.3.   Examination of clinical data <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.3.     Devices placed on the market in sterile
condition</span></div>
<div>
<span style="font-size: 12pt; line-height: 115%;">3.6.3.1.  <b><i><u>first possibility</u></i></b></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.3.2. Second possibility : <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.4.   <b><i>Establishing</i></b> biocompatibility <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.5.   Establishing microbiological safety <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.6.   <b><i><u>Devices</u></i></b> with a measuring function <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.7.   <b><i><u>Devices</u></i></b> that incorporate medicinal drugs <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">3.6.8.   Device previously considered as medicines
for placing on the market <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<b><span style="font-size: 12.0pt; line-height: 115%;">3.7.     Course of the procedure with LNE / G-MED <o:p></o:p></span></b></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<br /></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 18.0pt; line-height: 115%;">4.       <b><i><u><a href="http://www.blogger.com/SIEN%20Consultants%20is%20a%20leading%20Consultant%20&%20Training%20firm%20for%20ISO%209001%20%7C%20Sertifikat%20ISO%209001:2008,%20QMS,%20Sistem%20Manajemen%20Mutu%20%7C%20Konsultan%20ISO%20&%20Pelatihan%20ISO%209001%20Terbaik%20No.1%20Indonesia." target="_blank">CE marking </a></u></i></b><o:p></o:p></span></div>
<div>
<span style="font-size: 18.0pt; line-height: 115%;"><br /></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">5.       <b><u>Maintaining</u></b> the advantage of CE marking <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">5.1.     <b><i><u>Full quality</u></i></b> assurance system <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">5.1.1.  Where product design examination has been
<b><i><u>carried</u></i></b> <u><i><b>out </b></i></u><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">5.1.2.   General case <o:p></o:p></span></div>
<div>
<span style="font-size: 12.0pt; line-height: 115%;"><br /></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">5.2.
<b><u><i>Production quality assurance </i></u></b><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">5.3. Product
quality assurance <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">5.4. <b><i><u>EC type
examination </u></i></b><o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">5.5. EC
verification <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">5.6. <b><u><i>EC
declaration</i></u></b> of conformity <o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<div>
<span style="font-size: 12.0pt; line-height: 115%;">5.7.
<b><i><u>Verification of manufactured</u></i></b> products<o:p></o:p></span></div>
</div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-size: 12.0pt; line-height: 115%;"><br /></span>
<span style="font-size: 12.0pt; line-height: 115%;"><br /></span></div>
<div class="MsoListParagraph" style="tab-stops: .25in; text-align: center;">
<span style="color: red; line-height: 115%;">Any Company interesting Relationship
, please call us now</span><span style="font-family: "Baskerville Old Face","serif"; line-height: 115%;"><span style="color: red;">:</span><o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: center;">
<b><br /></b></div>
<div class="MsoNormal" style="text-align: center;">
<b><span lang="FI" style="color: #333333; font-family: "Arial","sans-serif"; font-size: 12.0pt; line-height: 115%; mso-ansi-language: FI; mso-bidi-font-family: Arial; mso-bidi-theme-font: minor-bidi;"><a href="http://strategibisnisdanisoseries.wordpress.com/2013/01/30/company-profile-of-sien-consultant/">Ali
Pur MR     </a> <o:p></o:p></span></b></div>
<div class="MsoNormal" style="text-align: center;">
<b><span lang="FI" style="color: red; font-family: "Arial","sans-serif"; font-size: 12.0pt; line-height: 115%; mso-ansi-language: FI; mso-bidi-font-family: Arial; mso-bidi-theme-font: minor-bidi;">PT. Sien Consultan  <o:p></o:p></span></b></div>
<div class="MsoNormal" style="text-align: center;">
http://indokonsultan.com<br />
<a href="http://indokonsultan.com/consultants-ce-i-konsultan-ce-marking-i-training-ce-mark/" target="_blank">SIEN Consultants is a leading Consultant & Training  for Ce Mark | Sertifikat ISO 9001:2008, QMS, Konsultan ISO & Pelatihan ISO series Terbaik No.1 Indonesia. I please call at : 081380163185   </a><br />
<br /></div>
<div class="MsoNormal" style="text-align: center;">
<b><span style="color: #333333; font-family: "Arial","sans-serif"; font-size: 12.0pt; line-height: 115%; mso-bidi-font-family: Arial; mso-bidi-theme-font: minor-bidi;">Head  Office</span></b><span style="color: #333333; font-family: "Arial","sans-serif"; font-size: 12.0pt; line-height: 115%; mso-bidi-font-family: Arial; mso-bidi-font-weight: bold; mso-bidi-theme-font: minor-bidi;"> : Jl. </span><span lang="SV" style="color: #333333; font-family: "Arial","sans-serif"; font-size: 12.0pt; line-height: 115%; mso-ansi-language: SV; mso-bidi-font-family: Arial; mso-bidi-font-weight: bold; mso-bidi-theme-font: minor-bidi;">Kyai Caringin No. 20A, Jakarta
Pusat   <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: center;">
<span style="color: #00b050; font-family: "Arial","sans-serif"; font-size: 12.0pt; line-height: 115%; mso-bidi-font-family: Arial; mso-bidi-font-weight: bold; mso-bidi-theme-font: minor-bidi;">Telp. :+6221. 98567515 , +62813801631.85 Fax. :
(62-21) 6306560 <o:p></o:p></span></div>
<h1 style="margin-top: 0in; text-align: center;">
<span style="font-size: small;"><span style="color: #333333; font-family: "Arial","sans-serif"; font-size: xx-small; mso-bidi-font-weight: normal;">Email : <a href="mailto:purbaali192@ymail.com"><span style="font-family: "Cambria","serif"; mso-bidi-font-family: "Times New Roman";">purbaali192@ymail.com</span></a>  or </span><span style="text-align: left;">   info@indokonsultan.com</span></span></h1>
<h1 style="margin-top: 0in; text-align: center;">
<span style="color: #333333; font-family: "Arial","sans-serif"; font-size: xx-small; mso-bidi-font-weight: normal;"><span style="font-size: small;">Skype : haliamsah_purba   </span><o:p></o:p></span></h1>
<div class="MsoNormal">
<br /></div>
</div>

CE MARKING MEDICAL DEVICES Guide

CE Marking Of MEDICAL DEVICES Guide CONTENTS 1. Introduction to the guide ...

Baca selengkapnya »

BISNIS STRATEGI DAN ISO SERTIFIKASI | 081380163185

CE MARKING CONSULTANT I Telp : +6221. 98567515 / +628138.0163185

CE MARKING MEDICAL DEVICES Guide

Postingan Populer

Advertisement

Arsip Blog